For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
Cell and gene therapies (CAGT) present new regulatory and manufacturing challenges, operational complexity, and obstacles to market and patient access. To help you navigate this complexity, we bring a team of 30+ cross-functional CAGT professionals that includes six ex-FDA regulators from the Center for Biologics Evaluation and Research (CBER)’s Office of Tissues and Advanced Therapies, the supervisory medical reviewer from one of the first approved CAR-T cell therapies, and chemistry, manufacturing, and controls (CMC) regulatory experts from EMA and MHRA.
Our Cell and Gene Therapy Center of Excellence (COE) integrates regulatory expertise with a cross-functional team to get your treatment to market faster. This team includes medical directors and regulatory affairs experts, as well as experts in clinical logistics, CMC, oncology clinical operations, data management, translational medicine, and biostatistics. They also align closely with our patient engagement team, with leadership reporting directly to our Chief Patient Officer to ensure vital patient insights are applied at every stage of development.
Our experts in cell and gene therapies
To streamline development for novel treatments, it’s vital to prepare a strong scientific argument and proof of concept before meeting with regulatory agencies. That’s why we combine an early advisory service of medical, regulatory, genomics, and biostatistical specialists with an experienced, multidisciplinary team and key technology platform partnerships — to give you a faster, smarter route to proof of concept.
At Parexel, we use a global health research network to access EMR data for 188+ million patients worldwide. This network empowers us to identify global specialty institutions treating patients with specific ICD-10 codes, treatments, diagnoses, and procedures — so we can match sites to your essential study criteria.
Our Cell and Gene Therapy Training Academy trains staff from across our business to improve performance across trials. Modules cover a variety of topics, including history, patient pathways, safety risks, operational fundamentals in delivering cell and gene therapy, and the study-specific content/mechanism of action/route.
Our expert staff in biomarker and genomic medicine, bioanalysis, modeling and simulation, and clinical pharmacology combine scientific rigor and patient-community engagement to maximize patient inclusion. We focus on high-quality delivery and understanding of study settings, driven by a skilled and flexible project management team. We listen to the voices of patients, their caregivers, and healthcare professionals, so they can confidently decide if the trial is right for them. And we ensure that the patient perspective is retained throughout the duration of the trial.
Find confidence in our experienced project and delivery teams.
Benefit from our regulatory and CMC consulting expertise.
Accelerate startup with a network of 1,400+ sites
Recruit and retain even difficult-to-find patient populations
Access our non-clinical and clinical development strategy
Align your trials with GTP, GMP, and GCP (GXP) compliance.
Utilize our market access strategy and value communications
Tap into our genomics research, methods, and resources
Want to hear from our experts on the latest topics in cell and gene therapy? Visit our Insights Center to read, watch, and listen.